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Last Updated: February 28, 2021

DrugPatentWatch Database Preview

Bupropion hydrobromide - Generic Drug Details

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What are the generic sources for bupropion hydrobromide and what is the scope of freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-three patent family members in eighteen countries.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide
Recent Clinical Trials for bupropion hydrobromide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Medical University of South CarolinaPhase 1
Valeant Pharmaceuticals International, Inc.Phase 4

See all bupropion hydrobromide clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial522MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial174MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bupropion hydrobromide
Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-12-24
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-09-28
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-09-24

US Patents and Regulatory Information for bupropion hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for bupropion hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 17C1058 France   Start Trial PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 122017000109 Germany   Start Trial PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 132017000142109 Italy   Start Trial PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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